The Effects of Testosterone on Prostate Tissue (ACYP-1)

University of Washington

Status and phase: Completed; Phase 1

Conditions: Contraception; Hypogonadism

Treatments: Drug: Placebo Testosterone gel; Drug: Placebo acyline; Drug: Testosterone gel; Drug: Acyline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00161486

U 54 HD42454

03-9401-B

Details and patient eligibility

About

The purpose of this research study is to understand the effects of testosterone on the prostate. This knowledge will be used to help in the development of a safe male hormonal contraceptive and may impact the development of androgen replacement therapy in older men.

Full description

We will be administering two drugs: Testim (testosterone gel) and Acyline. Acyline is an experimental drug. We want to see their effects on levels of hormones in the blood and prostate. In addition, we will be examining the effects of these drugs on the expression of genes within the prostate.

Acyline suppresses LH and FSH, which are hormones made by the pituitary gland, thus blocking the signal from the brain that causes the testes to make testosterone. Therefore, Acyline blocks testosterone production. In preliminary studies, a single injection of Acyline reversibly lowered the FSH, LH and testosterone levels in the blood for approximately 15 days. Prolonged low levels of LH and FSH cause suppression of sperm production in normal men. However, men may experience some side effects from the low levels of testosterone caused by acyline, thus exogenous testosterone is required to sustain normal male androgen and organ effects without suppressing spermatogenesis. This combination of drugs is a promising male contraceptive regimen. In addition, millions of older men are using testosterone replacement to treat male "andropause"; low level testosterone associated with aging. However, the effect of testosterone on the prostate is unknown. Studies examining the effect of testosterone on the prostate are needed.

Enrollment: 13 patients

Sex: Male

Ages: 35 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males between 35 and 55, normal serum testosterone levels, normal gonadal function

Exclusion criteria

• History of prostate cancer, PSA>2.0, AUA BPH symptom score >10, History of testosterone or anabolic steroid use, chronic medical illness or prostate disease, active serious infection or immunosuppression, history of a bleeding disorder or need for anticoagulation, abnormal digital rectal exam, abnormal prostate ultrasound, first degree relative with history of prostate cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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13 participants in 3 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo acyline injections every two weeks (2 doses) + placebo testosterone gel daily for 4 weeks

Treatment:

Drug: Placebo acyline

Drug: Placebo Testosterone gel

2

Active Comparator group

Description:

Acyline 300 μg/kg every two weeks (2 doses) + placebo Testosterone gel daily for 4 weeks

Treatment:

Drug: Placebo Testosterone gel

Drug: Acyline

3

Active Comparator group

Description:

Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks + Testosterone gel 100 mg daily for 4 weeks

Treatment:

Drug: Testosterone gel

Drug: Acyline